MalfunctionHTW
NA
Received Jul 21, 2021 · Event occurred Jun 18, 2021
Report 12202210 · MDR key 12202210
Device
Generic name
Bit, Drill
Manufacturer
Sterilmed, Inc.Model number
KOMKM166-00-01Catalog number
KM166-00-01
Product problems
- Break
Patient
23360 DA
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
A SMALL PIECE OF THE STERILMED DRILL BIT TWIST STAINLESS STEEL BROKE OFF AND LODGED IN THE ANTERIOR ASPECT OF THE HUMERUS. THE FRAGMENT WAS LEFT IN PLACE INTENTIONALLY SO AS NOT TO COMPROMISE THE INTEGRITY OF THE PROXIMAL HUMERUS OR THE HUMERAL STEM FOR THE PROSTHESIS